Guangdong Provincial Endometriosis Clinical Research Cohort
研究概览
地位
条件
详细说明
This is a prospective observational cohort study designed to characterize the clinical course and reproductive outcomes of women with endometriosis. The study will prospectively enroll women aged 18 to 45 years with a clinical, imaging, or surgical diagnosis of endometriosis. Age- and body mass index-matched healthy women with regular menstrual cycles may also be enrolled as a control cohort.
Baseline data will include demographic characteristics, reproductive history, lifestyle factors, clinical symptoms, pain scores, disease phenotype, lesion characteristics, rASRM stage, previous surgery, laboratory findings, ovarian reserve indicators, and assisted reproductive treatment information, when applicable. Treatments received as part of routine clinical care, including gonadotropin-releasing hormone agonists and progestogens, will be recorded as observational exposures. The study protocol will not assign participants to a specific medication, procedure, or assisted reproductive treatment.
Participants will be followed for 24 months. Follow-up assessments will be conducted every 3 months during the first year and every 6 months thereafter, with clinically important outcome events recorded when they occur. Outcomes of interest include cyst recurrence, pain recurrence, pregnancy outcomes, live birth, and other long-term clinical complications.
Associations between baseline clinical characteristics, disease severity, routine treatment patterns, and subsequent outcomes will be evaluated using appropriate descriptive and multivariable statistical methods. Time-to-event outcomes may be analyzed using Kaplan-Meier methods and Cox proportional hazards regression, with adjustment for potential confounding factors.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Li Li, MD
- 电话号码:+85213631446859
- 邮箱:lili-1406@163.com
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、511442
- 招聘中
- Guangdong Women and Children Hospital
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接触:
- Li Li, MD
- 电话号码:+85213631446859
- 邮箱:lili-1406@163.com
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接触:
- Li Li, MD
- 邮箱:lili-1406@163.com
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Inclusion Criteria:
Female participants aged 18 to 45 years. Able and willing to provide written informed consent. For the endometriosis cohort: diagnosis of endometriosis based on clinical findings, imaging, and/or laparoscopy.
For the endometriosis cohort: availability of complete baseline clinical data, including revised American Society for Reproductive Medicine stage and lesion type.
For the healthy control cohort: healthy women matched by age and body mass index to participants in the endometriosis cohort.
For the healthy control cohort: regular menstrual cycles of 28 to 30 days.
Exclusion Criteria:
For the endometriosis cohort: concurrent malignant tumor or severe cardiac, hepatic, or renal disease.
For the endometriosis cohort: previous hysterectomy. For the endometriosis cohort: a mental disorder that prevents adherence to study follow-up.
Exclusion Criteria:
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学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Endometriosis Cohort
Women aged 18 to 45 years with endometriosis diagnosed based on clinical findings, imaging, and/or laparoscopy will be prospectively enrolled and followed for 24 months.
Baseline disease characteristics, routine clinical treatments, pain outcomes, cyst recurrence, and reproductive outcomes will be recorded.
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Healthy Control Cohort
Age- and body mass index-matched healthy women aged 18 to 45 years with regular menstrual cycles of 28 to 30 days will be prospectively enrolled as a comparison cohort.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Endometriosis-Related Pain Recurrence
大体时间:From enrollment through 24 months
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The number and percentage of participants in the endometriosis cohort who experience recurrence of endometriosis-related pain during follow-up.
Pain severity will be assessed using a visual analogue scale and clinical symptom records
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From enrollment through 24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Endometriosis-Related Cyst Recurrence
大体时间:From enrollment through 24 months
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The number and percentage of participants in the endometriosis cohort with a recurrent endometriosis-related cyst documented during follow-up.
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From enrollment through 24 months
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Live Birth During Follow-Up
大体时间:From enrollment through 24 months
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The number and percentage of participants in the endometriosis cohort with a live birth during follow-up.
Live birth is defined as delivery of a live infant at 28 gestational weeks or later.
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From enrollment through 24 months
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合作者和调查者
赞助
出版物和有用的链接
一般刊物
- Sharma S, Bathwal S, Agarwal N, Chattopadhyay R, Saha I, Chakravarty B. Does presence of adenomyosis affect reproductive outcome in IVF cycles? A retrospective analysis of 973 patients. Reprod Biomed Online. 2019 Jan;38(1):13-21. doi: 10.1016/j.rbmo.2018.09.014. Epub 2018 Oct 26.
- Marcellin L, Leconte M, Gaujoux S, Santulli P, Borghese B, Chapron C, Dousset B. Associated ileocaecal location is a marker for greater severity of low rectal endometriosis. BJOG. 2019 Dec;126(13):1600-1608. doi: 10.1111/1471-0528.15901. Epub 2019 Sep 4.
- Rowlands IJ, Abbott JA, Montgomery GW, Hockey R, Rogers P, Mishra GD. Prevalence and incidence of endometriosis in Australian women: a data linkage cohort study. BJOG. 2021 Mar;128(4):657-665. doi: 10.1111/1471-0528.16447. Epub 2020 Sep 1.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GDWCH-ENDO-PROS-01
- 20250070 (其他标识符:Guangdong Women and Children Hospital Ethics Committee)
- 20250134 (其他标识符:Guangdong Women and Children Hospital Clinical Research Management Committee)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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